Quantitative determination of C-reactive protein (CRP) in human serum and plasma on Siemens Systems

Quantitative determination of C
CardioPhase® hsCRP - 10446090

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQD

Device Name: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Device Class: 2

Physical State: N/A

Definition: In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5270

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00842768007729

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 00842768019012

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A